UW LABORATORY FOR PRECISION DIAGNOSTICS NORTHWEST CLINICAL GENOMICS LABORATORY

1959 NE PACIFIC AVE., LAB H-561, SEATTLE, WA 98195

PHONE: 206-543-0459; FAX: 206-616-1899 www.uwcpdx.org

Name: Name:

Address: Organization:

City: State: ZIP: Address:

Phone: City: State: ZIP:

Patient ID (MRN): Phone: FAX:

Date of birth: Email:

Gender: Male Female Unknown

Ethnic background (select all that apply): Name:

Hispanic Address:

Asian City: State: ZIP:

Native American Phone: FAX:

African American ite) Caucasian (White) Ashkenazi Jewish Other: Email:

Date of collection:

Date of birth: Patient ID (MRN):

Clinical (Affected/Unaffected):

Date of birth: Patient ID (MRN):

DNA

Specimen type: Whole blood (EDTA tube) Extracted DNA Other:

FAMILIAL SAMPLES Mother: Father:

Saliva Date of birth:

PATIENT INFORMATION ORDERING PHYSICIAN

OTHER REPORT RECIPIENT

SAMPLE INFORMATIONCollected by:

Relative: Relative:

Patient ID (MRN): Date of birth:

TEST TO BE PERFORMED

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EXOME AND GENOME TEST REQUISITION

Exome Trio Sequencing and Interpretation (Proband, Mother, Father)

Exome Duo Sequencing and Interpretation

Exome Singleton Sequencing and Interpretation (Proband only)

Exome Comparator Sequencing and Interpretation (Additional family member for support of proband testing)

Relative's relationship to Proband: Proband Name:

Reflex Exome Sequencing - (only after completion of exome "panel")

RAPID option for Exome Sequencing and Interpretation (10 day TAT; additional charges apply)

Saliva

Sample type: Blood

Relationship:

Patient ID (MRN):

Genome Trio Sequencing and Interpretation

Genome Duo Sequencing and Interpretation

Genome Singleton Sequencing and Interpretation (Proband only)

Genome Comparator Sequencing and Interpretation (Additional family member for support of proband testing)

Relative's relationship to Proband: Proband Name:

Other: DNASalivaSample type: Blood Other:

DNASalivaSample type: Blood Other: DNASalivaSample type: Blood Other:

Clinical (Affected/Unaffected):

Clinical (Affected/Unaffected): Clinical (Affected/Unaffected):

Relationship:

Indication for Study and Pertinent Clinical Information (provide any suspected clinical diagnoses or state if unaffected):

Previous Genetic Testing: No Yes - Provide results: ______________________________________________________

Suspected Mode of Inheritance: Dominant Recessive X-linked De novo Mitochondrial

Medical History: For any section marked "Abnormal" please provide additional informationICD-9 Code(s): ______________

Perinatal / Prenatal History: Skeletal: Abnormal Normal Unknown Abnormal Normal Unknown

In Utero Abnormalities of Proband: Muscle, Soft Tissue: Abnormal Normal Unknown Abnormal Normal Unknown

Growth and Build: Neurologic: Abnormal Normal Unknown Abnormal Normal Unknown

Head and Neck: Skin, Nails, Hair: Abnormal Normal Unknown Abnormal Normal Unknown

Voice: Immunology: Abnormal Normal Unknown Abnormal Normal Unknown

Chest and Thorax: Endocrine System: Abnormal Normal Unknown Abnormal Normal Unknown

Cardiovascular: Hematology: Abnormal Normal Unknown Abnormal Normal Unknown

Respiratory: Metabolic: Abnormal Normal Unknown Abnormal Normal Unknown

Abdomen: Neoplasia: Abnormal Normal Unknown Abnormal Normal Unknown

Genital System: Abnormal Laboratory Results: Abnormal Normal Unknown Abnormal Normal Unknown

Urinary System: Abnormal Normal Unknown

Please list any genes for which you are requesting specific analysis or note any special requests here. (Please note: The lab will also generate a list of genes and variants based on clinical features and indication of study unless directed otherwise):

______________________________________________________________________________________________________________

CLINICAL INFORMATION

______________________________________________________________________________________________________________ ______________________________________________________________________________________________________________

Patient name: ____________________________________________________ Date of birth: ________________ (MM/DD/YYYY)REQUISITION FORM

______________________________________________________________________________________________________________

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BILLING INFORMATION AND AUTHORIZATION 1. BILL INSTITUTIONInstitution: Tax ID #: PO#: Claims Billing Address: City: State: Zip: Billing Contact Name: Phone: FAX:

2. BILL INSURANCE Preauthorization is required for all insurance billing

Do insurance preauthorization; PROCEED if approved (PREAUTH FORM and sample required) Do insurance preauthorization CONTACT PROVIDER if approved (PREAUTH FORM and sample required) Preauthorization already obtained; PreAuth approval number:

Policyholder Name: Relationship to Patient: Self Parent Spouse Other (specify): Policyholder DOB: Dates of Coverage: Patient Policy ID#: Group Name: Group #: Insurance Company Name: Claims Billing Address: City: State: Zip: Phone: FAX: ICD10 Diagnosis Code(s): Patient Insurance Billing Consent: I authorize the NCGL to release to my designated insurance carrier, health plan, or third party administrator the information on this form and any other information provided by my health care provider necessary for reimbursement. I assign and authorize insurance payments to NCGL. I understand my insurance carrier may not approve and reimburse my medical genetic services in full due to usual and customary rate limits, benefit exclusions, coverage limits, lack of authorization, medical necessity, or otherwise. I understand I am responsible for fees not paid in full, co-payments, and policy deductibles except where my liability is limited by contract or State or Federal law. A duplicate or faxed copy of this authorization is considered the same as the original document.

Patient Signature: Date:

3. SELF-PAYPayment Method: Cashier Check/Money Order (Payable to UW Physicians)

Credit Card: Please contact NCGL billing at (206) 221-1274 to provide credit card information over a secure line Electronic Funds Transfer (EFT) (See website for details) EFT Amount (USD):

4. MEDICAIDFor Medicaid billing, the following is required: Medicaid claims address, Copy of Medicaid card (attach to requisition form), Letter of medical necessity from referring physician; impact on future care (attach to requisition form)

5. MEDICAREFor Medicare billing, a completed Advance Beneficiary Notice (ABN) is required (see website for form)

SAMPLE & SHIPPING REQUIREMENTS Blood samples should be collected in lavender top (potassium EDTA) tubes: 7mL (3-5mL for infants). All samples must be labeled with two unique identifiers: 1) the patient's full name and 2) date of birth. If possible please include the patient's medical record number. Please contact the laboratory for more details and test kits (206-543-0459).

Samples must be accompanied by a requisition form and signed consent forms (when applicable). Sample (with forms) should be shipped overnight at room temperature to:

Laboratory for Precision Diagnostics Northwest Clinical Genomics Laboratory

1959 NE Pacific St., HSC H-561 Seattle, WA 98195

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Last revised: 11 June 2019

UW Laboratory Center for Precision Diagnostics Northwest Clinical Genomics Laboratory Box 357655 1959 NE Pacific St., HSC H-561, Seattle, WA 98195

Phone: 206-616-4115 206-221-9364www.uwcpdx.org cpdx@uw.edu

Patient Name: __________________________________________ Date of Birth: ___________________ (MM/DD/YYYY)

CONSENT FOR CLINICAL EXOME OR GENOME (GENOMIC) SEQUENCING

Test ordered: ______ Exome sequencing (sequencing of the coding portions of the genome) ______ Genome sequencing (sequencing of the coding and non-coding portions of the genome)

Exome and genome sequencing tests are referred to as “genomic sequencing” throughout the following consent form. The technical limitations and caveats are applicable to both.

Please read this form carefully. You are being offered a blood test that examines your genetic material. This testing may help us better understand your/your child's medical condition. This consent form will explain the testing, how results are released and potential risks and benefits of doing the test and possible costs. In addition, this form will describe what is known and not known about genomic sequencing (GS) at present. GS is a new lab technique that is changing quickly. Your healthcare provider will help you understand the information on the consent form and answer any questions that you have.

You should keep your healthcare provider updated with your current contact information. This will make it possible for us to contact you if we learn important information from this testing now or in the future.

1. What is the purpose of the genomic sequencing (GS) test ?The purpose of this test is to examine the DNA sequence of each gene in the body to try to find genetic changes that might play a rolein the cause of your/your child’s health with respect to the following conditions(s):____________________________________________________________________

2. What must be provided for GS testing ?You/your child will be asked to provide a blood or other tissue sample for testing. Medical history and family history information will berequested to assist in interpreting the test results. Once testing is completed, additional medical or family history information, orfurther medical tests may be recommended to better interpret the test results. At times we may request similar testing samples fromrelatives for comparison. If a comparator sample is submitted, the relative should also fill out and submit a Comparator Consent Form.

3. What does the GS test look for ?This test looks for gene sequence (DNA) changes that are associated with specific genetic disorders. The test may find changes inone gene or in many that cause or contribute to your/your child’s condition. It is possible that this test will not find any changes thatexplain your/your child’s condition. This "normal GS result" would not mean that you/your child do not have or will not develop agenetic disorder, only that with the current technology we cannot find the exact cause

4. What other information can the GS test tell me ?The test may find genetic changes that tell us that you/your child are at risk for disorders other than your/your child’s condition, suchas cancer risk. These changes are referred to as “incidental” or secondary findings. If incidental findings are thought to be medicallyimportant for you/your child, the NCGL will report the results to your/your child’s healthcare provider. Your/your child’s healthcareprovider will talk to you about how these findings may change your/your child’s risk for this additional condition and/or its medical use.

5. What are the limits of the genomic sequencing test ?Although, the GS test method will find a large number of genetic changes, there remain a small number of DNA changes that it will notdetect. For the changes that we find, we may not know whether they lead to the disorder or are normal changes in gene sequence. Itmay be many years before we understand what all of the changes mean and are able to find a change that causes or contributes toyour/your child’s condition.

6. How will I learn the results of my genomic sequencing test ?You will learn the results of this test from: ___________________________________ . This healthcare provider will receive alaboratory report that discusses the results that may be relevant to the reason you/your child had testing. Your/your child’s healthcareprovider will share this information with you and a genetic counselor may assist in explaining the results.

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Last revised: 11 June 2019

UW Laboratory for Precision Diagnostics Northwest Clinical Genomics Laboratory Box 357655

1959 NE Pacific St., HSC H-561, Seattle, WA 98195 Phone: 206-616-4115 206-221-9364

www.uwcpdx.org cpdx@uw.edu

Patient Name: __________________________________________ Date of Birth: ___________________ (MM/DD/YYYY)

7. How long will it take to get my results ?The Northwest Clinical Genomics Lab (NCGL), the laboratory performing this test, expects to complete GS in 3 months time. Factorssuch as the need to repeat some part of the test or to test other family members to help with interpretation may extend the timeline.We will get the results to your healthcare provider as quickly as possible.

8. Will I get all of my results at once ?All results that we find (that you have agreed to receive) will be reported in the initial report. Because the understanding of DNAchanges will improve over time, it is likely that more will be understood about your results later, after you get your initial report. If newinformation is discovered that is thought to be important to your/your child's health and/or the health of your relatives, your/your child’shealthcare provider will be re-contacted If you would like an updated report, you should contact your healthcare provider or theNCGL. There may be a charge for a new interpretation of your results.

9. What are the risks of the genomic sequencing test to you and your family ?You may learn medical information about yourself/your child that you did not expect. Learning that you/your child are at risk for acondition other than your/your child’s condition for which the test is done, and which may not be preventable or treatable, could lead toemotional or psychological distress.You may discover things about yourself/your child that trouble you and that you may not have the ability to control or change. Forexample, unexpected parental relationships or other information about your ancestry could be uncovered.Your relatives may be upset to learn that they may be at risk for a disease.The test will give us a lot of information, but we might not know what all of it means right away. It is possible that this test will not findthe cause of your/your child’s condition, or the test may not tell us your/your child’s chance of developing specific disorders. Thiscould be frustrating or upsetting.Although there are laws to prevent employment and health insurance discrimination based upon genetic findings, there are currentlyno laws to prevent the use of genetic information to alter the ability to obtain life, disability or long-term insurance or their cost.

10. How could the genomic sequencing test affect my family members ?This test could reveal information about the health of your relatives, such as their chances of developing certain disorders. Suchinformation could be unexpected, or it could explain a medical condition in your family. If the test finds a genetic change that may beimportant to your family’s health, you/your child’s healthcare provider will ask you to tell your family members about it.This test will find many changes that we cannot interpret. In this case, testing your parents or other family members to see if theyhave the same change may help understand certain results. Your/your child’s healthcare provider may ask you if your familymembers would be willing to have genetic testing. Certain follow-up testing may be performed free of charge.

11. Will my genetic information become part of my medical record ?Your/your child’s genomic sequencing report will list medically important genetic changes that were found by the genomic sequencingtest. The report that contains your/your child’s test results as well as any updates to those results will become part of your/your child’spermanent electronic medical record and can be made available to any healthcare provider who treats you now or in the future. Yourprotected health information will be used in accordance with the terms of the UW Medicine Healthcare Privacy policies. As weunderstand more about genetic changes, your/your child’s report and medical record may be updated. The laboratory will not initiallydeposit your complete genome sequence into your/your child’s medical record. However, it is possible that this policy will change inthe future in which case your/your child’s complete genetic sequence may be incorporated into your/your child’s permanent medicalrecords.

12. Will anyone else have access to my genome sequence, shared medical history or interpreted results ?Test results and submitted clinical information may be shared with other clinical laboratories to improve our understanding of therelationship between genetic changes and clinical symptoms and findings. Sharing data in this manner may enable us to providebetter interpretations of your genetic findings as well as assist other patients with similar results. We will protect yourprivacy/confidentiality by replacing your name and other direct identifiers, such as date of birth or medical record number, with a code.The key to the code numbers will be stored securely in the testing laboratory. We will share only de-identified information with outsideclinical laboratories.

13. Who besides my physician can I talk to if I have more questions about the genomic sequencing test ?You may request the name and phone number of a genetic counselor who can answer your questions about the genomic sequencingtest and help you understand your/your child’s results.

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UW Laboratory for Precision Diagnostics Northwest Clinical Genomics Laboratory

959 NE Pacific St., HSC H-561, Seattle, WA 98195 Phone: 206-616-4115 206-221-9364

www.uwcpdx.org cpdx@uw.edu

Patient Name: __________________________________________ Date of Birth: ___________________ (MM/DD/YYYY)

14. How will my blood sample and genetic information be used after testing is completed?After performing your test, the laboratory may use your/your child’s remaining sample to do quality control checks and/or develop newand better laboratory tests. Your/your child’s name and other identifying information will be removed from the sample before it is usedin these ways. In addition, your de-identified sample may be used in accordance with the research policies stated in the followingsection. There will be no additional charge to you for using your/your child’s sample in these ways.

15. Will I have to pay for the genomic sequencing test?Your health insurance may not cover the cost of this test. You will need to pay any portion of this test that is not covered by yourhealth insurance. You may also have medical visits to follow up on the results of this test. Insurance coverage for such tests will besubject to current medical practice and your insurance policy coverage.If you seek insurance coverage for this test, you may be required to release your/your child’s results to your health insurancecompany for payment purposes.

Optional Disclosure

Diagnostic Findings Not Related to the Target Clinical Condition in Adult-onset Medically Actionable Disorders: Medically actionable conditions are those for which there is current recommended treatment or preventative actions that can be taken to reduce risk of developing the complications of an adult-onset disorder. An example would be hereditary cancer syndromes where periodic medical screening may identify the cancer early. You can choose whether you want us to report the presence of such DNA changes in adult-onset disorders. Because an individual may have a DNA change of a medically actionable gene that will not be detected by the GS method, based on one's family history, additional testing for health purposes should be discussed with your doctor or genetic counselor.

YES, report information regarding adult-onset actionable conditions. _____ Patient/Guardian Initials NO, DO NOT report information regarding adult-onset actionable conditions. _____ Patient/Guardian Initials

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Comparators - Testing of a relative for Comparison

If a comparator sample is submitted, the relative should also fill out and submit a Comparator Consent Form.

Last revised: 11 June 2019

UW Laboratory for Precision Diagnostics Northwest Clinical Genomics Laboratory Box 357655

1959 NE Pacific St., HSC H-561, Seattle, WA 98195 Phone: 206-616-4115 206-221-9364

www.uwcpdx.org cpdx@uw.edu

Patient Name: __________________________________________ Date of Birth: ___________________ (MM/DD/YYYY)

RESEARCH POLICIES & OPPORTUNITIES

Blood or other samples sent to the Northwest Clinical Genomics Laboratory (NCGL) may be used by UW Medicine, by medical organizations affiliated with UW Medicine, or by educational or business organizations approved by UW Medicine, for research, education and other activities that support UW Medicine’s mission, without your/your child's specific consent. Other types of research performed in association with the NCGL require that we obtain consent from the patient (below).

PATIENTS – Please check off and initial below whether we can contact you to let you know about research studies requiring consent in which you/your child may be able to participate. These research studies may include: 1) a request for additional clinical records about your condition, 2) studies to find new causes for your condition, and 3) studies to evaluate newly developed treatments for your condition.

Patient Name: __________________________________________ Date of Birth: ______ / ______ / _________ (MM/DD/YYYY)

Please check one: Yes, you can contact me _______ (Patient/Guardian initials) If yes, please provide your contact information on the first page of the requisition form.

No, please do not contact me _______ (Patient/Guardian initials)

PATIENT / GUARDIAN SIGNATURE

I have carefully reviewed the above. I have had my questions answered to my satisfaction. I consent to provide a sample for genetic testing by genomic sequencing.

____________________________________________ _____________________ _________________ AM / PM Patient/Guardian Signature Date Time

____________________________________________ _________________________________________ Patient Name (Print) Guardian, if applicable (Print)

________ I agree that my family history information and my/my child’s personal medical information, including results of the exome sequencing test, may be shared among all of my/my child’s family members.

PROVIDER SIGNATURE

I, _____________________________________________ (print name), as ordering provider, confirm that I understand and accept that the patient being tested and/or their legal guardian have been informed of the risks, benefits, expectations and limitations of the testing ordered, as well as the policies of the NCGL listed above. I have obtained informed consent, as required by my own state and/or federal laws. In addition, I assume responsibility for returning the results of genetic testing to my patient and/or their legal guardian and for ensuring that my patient receives appropriate genetic counseling to understand the implications of their test results.

___ Other NP PA

____________________________________ MD ___________________ ______________ ___________ AM / PM Signature NPI # Date Time

3DJH�4�RI�4Last revised: 11 June 2019